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FDA 510(k)

HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807

K-Number: K925551 · 1993-04-20

ApplicantHichem Diagnostics
Decision Date1993-04-20
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1993-04-20 under 510(k) number K925551. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807?

HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 is a medical device that received FDA 510(k) clearance on 1993-04-20. The listed applicant is Hichem Diagnostics. The 510(k) number is K925551.

When did HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 receive FDA 510(k) clearance?

HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 received FDA 510(k) clearance on 1993-04-20, under 510(k) number K925551.

Who is the listed applicant for HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807?

The FDA 510(k) record lists Hichem Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807?

The FDA product code for HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 is CGA.

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Other records listing Hichem Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953863HICHEM ISE STANDARDS KIT 70011K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953862HICHEM ISEKCI SOLUTION KIT 70010

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Related Devices (Code: CGA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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